Oral Hygiene, Oral HealthBABYPLAKNCT06765343
Efficacy of Guided Biofilm Therapy in Pediatric Patient
A study testing Plaque disclosing agent, Guided Biofilm Therapy and Ultrasonic debridement and polishing in people with Oral Hygiene, Oral Health and Pediatric Pain and Anxiety, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
The present parallel randomized clinical trial aims to assess the efficacy of a plaque disclosing agent (PDA) and air-flowing with erythritol powder (Guided Biofilm Therapy) in the removal of biofilm and plaque in paediatric participants during professional oral hygiene, compared with ultrasonic debridement. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, Oral Health, Pediatric Pain and Anxiety
- What is being tested?
- Plaque disclosing agent, Guided Biofilm Therapy and Ultrasonic debridement and polishing
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2023to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Signed Informed Consent Form (pediatric patient and parent).
- Male and female subjects, aged 6 -12 years, inclusive.
- Good general health (ASA I e II)
- With at least 80% of dentition present
- With at least 8/12 frontal dental elements.
Who cannot join
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
- History of allergy to Erythritol.
- History of adverse reactions to lactose or fermented milk products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Guided Biofilm Therapy in Pediatric Patient: a Randomized Clinical Trial
The present parallel randomized clinical trial aims to assess the efficacy of a plaque disclosing agent (PDA) and air-flowing with erythritol powder (Guided Biofilm Therapy) in the removal of biofilm and plaque in paediatric participants during professional oral hygiene, compared with ultrasonic debridement.
The participants will be divided in four groups and receive:
Read more
- Guided Biofilm Therapy with plaque disclosing agent (GBT+)
- Guided Biofilm Therapy without plaque disclosing agent (GBT-)
- Ultrasonic debridement and polishing with plaque disclosing agent (US+C+)
- Ultrasonic debridement and polishing without plaque disclosing agent (US+C-)
Clinical and image software analysis (ImageJ) of residual plaque will be performed.
Read the detailed description
Oral biofilm is not easily detectable visually, so its removal can be difficult. Using a plaque disclosing agent to highlight biofilm and plaque could aid during its removal and may be beneficial.
In paediatric patients, often times it is more difficult to perform professional oral hygiene because of lack of compliance. Our hypothesis is that the visual guide of the plaque disclosing might help obtaining a better result in terms of plaque removal. Moreover, the use of air-flowing could lead to several advantages compared to traditional professional oral hygiene (ultrasonic debridement and polishing cups), such as increased comfort and compliance, shorter treatment time, easier access to difficult areas and the minimal-invasiveness on soft and hard tissue.
The study is a mono-centric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design.
The primary outcome is the Residual Plaque Area (RPA) expressed in percentage of area with residual plaque highlighted by disclosing plaque agent. Secondary outcomes are Full Mouth Plaque Score (FMPS), treatment time and participants' feedback.
- Being tested
- Plaque disclosing agent, Guided Biofilm Therapy, Ultrasonic debridement and polishing
- Keywords
- guided biofilm therapy, discloser agent, airflowing, polishing, patient feedback
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque disclosing agentDevice
Dye agent binding to oral biofilm and plaque for visual detection
Guided Biofilm TherapyDevice
Utilisation of a air-polishing device conveying a jet of air, water and erythritol powder for plaque debridement on dental surfaces, followed by calculus removal with an ultrasonic scaler
Ultrasonic debridement and polishingDevice
Removal of plaque and calculus with an ultrasonic scaler, followed by surface polishing with a rubber cup and abrasive paste
| Study group | Role | What they receive |
|---|---|---|
| Guided biofilm therapy with plaque disclosing (GBT+) | Experimental | Participants assigned to the GBT+ receive professional air-flowing oral hygiene with erythritol powder followed by ultrasonic calculus removal, guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. Receives: Device: Plaque disclosing agent; Device: Guided Biofilm Therapy |
| Guided biofilm therapy without plaque disclosing (GBT-) | Experimental | Participants assigned to the GBT+ receive professional air-flowing oral hygiene with erythritol powder followed by ultrasonic calculus removal, without the guide of a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. Receives: Device: Guided Biofilm Therapy |
| Ultrasonic debridement and polishing with plaque disclosing (US+C+) | Experimental | Participants assigned to the US+C+ receive traditional professional oral hygiene (ultrasonic tip followed by rubber cup and polishing paste) guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. Receives: Device: Plaque disclosing agent; Device: Ultrasonic debridement and polishing |
| Ultrasonic debridement and polishing without plaque disclosing (US+C-) | Active comparator | Participant assigned to the US+C- receive traditional professional oral hygiene (ultrasonic tip followed by rubber cup and polishing paste) without the guide of a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. Receives: Device: Ultrasonic debridement and polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Plaque Area (RPA)
The percentage of area on which plaque is still present, as revealed by reapplication of a plaque disclosing agent, at the end of the treatment session. An intra-oral picture is taken and it is analyzed with a specific software: ImageJ
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Full Mouth Plaque Score (FMPS)
The percentage of full mouth residual plaque detected with plaque disclosing agent after the treatment
Measured: Through study completion, an average of 1 year
Time Session
The duration of treatment is noted and compared between groups
Measured: Through study completion, an average of 1 year
Participant Feedback
A satisfaction questionnaire (VAS Scale) is administered to the participant
Measured: Through study completion, an average of 1 year
Operator Feedback
A satisfaction questionnaire (VAS Scale) is administered to the operator
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start6 Mar 2023
- Primary completion22 Jul 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Hygiene, Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial, mono-centric, 2 by 2 parallel
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765343
- Sponsor's protocol ID
- BABYPLAK NP 5675
- Acronym
- BABYPLAK
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magda M, Eleonora S, Silvia M, Gianluca G, Annamaria S, Matteo D, Elisa M, Stefano C, Bardellini E. Air-Flowing and Plaque Disclosing for Professional Biofilm Removal in Paediatric Patients: A Randomized Controlled Clinical Trial of Four Techniques. Int J Dent Hyg. 2026 Oct 8. doi: 10.1111/idh.70175. Online ahead of print.
PubMed 42850746
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Guided Biofilm Therapy in Pediatric Patient: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06765343
- Acronym / sponsor ID
- BABYPLAK / BABYPLAK NP 5675
- Keywords
- guided biofilm therapy, discloser agent, airflowing, polishing, patient feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present parallel randomized clinical trial aims to assess the efficacy of a plaque disclosing agent (PDA) and air-flowing with erythritol powder (Guided Biofilm Therapy) in the removal of biofilm and plaque in paediatric participants during professional oral hygiene, compared with ultrasonic debridement.
The participants will be divided in four groups and receive:
- Guided Biofilm Therapy with plaque disclosing agent (GBT+)
- Guided Biofilm Therapy without plaque disclosing agent (GBT-)
- Ultrasonic debridement and polishing with plaque disclosing agent (US+C+)
- Ultrasonic debridement and polishing without plaque disclosing agent (US+C-)
Clinical and image software analysis (ImageJ) of residual plaque will be performed.
Detailed description
Oral biofilm is not easily detectable visually, so its removal can be difficult. Using a plaque disclosing agent to highlight biofilm and plaque could aid during its removal and may be beneficial.
In paediatric patients, often times it is more difficult to perform professional oral hygiene because of lack of compliance. Our hypothesis is that the visual guide of the plaque disclosing might help obtaining a better result in terms of plaque removal. Moreover, the use of air-flowing could lead to several advantages compared to traditional professional oral hygiene (ultrasonic debridement and polishing cups), such as increased comfort and compliance, shorter treatment time, easier access to difficult areas and the minimal-invasiveness on soft and hard tissue.
The study is a mono-centric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design.
The primary outcome is the Residual Plaque Area (RPA) expressed in percentage of area with residual plaque highlighted by disclosing plaque agent. Secondary outcomes are Full Mouth Plaque Score (FMPS), treatment time and participants' feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized clinical trial, mono-centric, 2 by 2 parallel
| Arm | Type | Receives |
|---|---|---|
| Guided biofilm therapy with plaque disclosing (GBT+) | Experimental | Device: Plaque disclosing agent, Device: Guided Biofilm TherapyParticipants assigned to the GBT+ receive professional air-flowing oral hygiene with erythritol powder followed by ultrasonic calculus removal, guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. |
| Guided biofilm therapy without plaque disclosing (GBT-) | Experimental | Device: Guided Biofilm TherapyParticipants assigned to the GBT+ receive professional air-flowing oral hygiene with erythritol powder followed by ultrasonic calculus removal, without the guide of a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. |
| Ultrasonic debridement and polishing with plaque disclosing (US+C+) | Experimental | Device: Plaque disclosing agent, Device: Ultrasonic debridement and polishingParticipants assigned to the US+C+ receive traditional professional oral hygiene (ultrasonic tip followed by rubber cup and polishing paste) guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. |
| Ultrasonic debridement and polishing without plaque disclosing (US+C-) | Active comparator | Device: Ultrasonic debridement and polishingParticipant assigned to the US+C- receive traditional professional oral hygiene (ultrasonic tip followed by rubber cup and polishing paste) without the guide of a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Signed Informed Consent Form (pediatric patient and parent).
- Male and female subjects, aged 6 -12 years, inclusive.
- Good general health (ASA I e II)
- With at least 80% of dentition present
- With at least 8/12 frontal dental elements.
Key exclusion criteria (6 listed)
- Not willing to follow the agreed protocol.
- Presence of orthodontic appliances.
- Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- Current radiotherapy or chemotherapy.
- History of allergy to Erythritol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plaque disclosing agentDye agent binding to oral biofilm and plaque for visual detection | Device | Guided biofilm therapy with plaque disclosing (GBT+), Ultrasonic debridement and polishing with plaque disclosing (US+C+) |
| Guided Biofilm TherapyUtilisation of a air-polishing device conveying a jet of air, water and erythritol powder for plaque debridement on dental surfaces, followed by calculus removal with an ultrasonic scaler | Device | Guided biofilm therapy with plaque disclosing (GBT+), Guided biofilm therapy without plaque disclosing (GBT-) |
| Ultrasonic debridement and polishingRemoval of plaque and calculus with an ultrasonic scaler, followed by surface polishing with a rubber cup and abrasive paste | Device | Ultrasonic debridement and polishing with plaque disclosing (US+C+), Ultrasonic debridement and polishing without plaque disclosing (US+C-) |
Primary outcome
Residual Plaque Area (RPA)
Time frame: Through study completion, an average of 1 year
The percentage of area on which plaque is still present, as revealed by reapplication of a plaque disclosing agent, at the end of the treatment session. An intra-oral picture is taken and it is analyzed with a specific software: ImageJ
4 secondary outcomes
Full Mouth Plaque Score (FMPS)
Time frame: Through study completion, an average of 1 year
Time Session
Time frame: Through study completion, an average of 1 year
Participant Feedback
Time frame: Through study completion, an average of 1 year
Operator Feedback
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 42850746Magda M, Eleonora S, Silvia M, Gianluca G, Annamaria S, Matteo D, Elisa M, Stefano C, Bardellini E. Air-Flowing and Plaque Disclosing for Professional Biofilm Removal in Paediatric Patients: A Randomized Controlled Clinical Trial of Four Techniques. Int J Dent Hyg. 2026 Oct 8. doi: 10.1111/idh.70175. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaque disclosing agent, Guided Biofilm Therapy and Ultrasonic debridement and polishing in people with Oral Hygiene, Oral Health and Pediatric Pain and Anxiety, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Plaque Area (RPA) (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06765343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.